AusPAR: Clobetasol propionate - Therapeutic Goods Administration

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Therapeutic Goods Administration01596-3-51, identified as the EU RMP Version 2 dated 11 May 2012, and anysubsequent revisions as agreed with the TGA and its Office of Product Review.2. It is a further condition of registration that the sponsor submits the results of clinicalstudies on use over 12 months, including duration of effect, interval to re-treatrnentand surveillance mechanisms for HPA axis suppression, to the TGA as soon as the databecome available.3. Prior to these goods being available for marketing the sponsor is required to submitto the TGA the specifications of a simple and reliable dispensing device, to be suppliedwith the product that allows for reproducibility of the recommended dose.Attachment 1. Product InformationThe following Product Information was approved at the time this AusPAR was published.For the current Product Information please refer to the TGA website at.Attachment 2. Extract from the Clinical EvaluationReportAusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5Final 22 May 2013Page 44 of 45
Therapeutic Goods AdministrationPO Box 100 Woden ACT 2606 AustraliaEmail: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605http://www.tga.gov.auReference/Publication #
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AusPAR: Clobetasol propionate - Therapeutic Goods Administration

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